{"eventGroups":[{"description":"Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy.\n\nDose Level I: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion.","id":"EG000","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":4,"seriousNumAtRisk":5,"title":"Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I)"},{"description":"Phase II patients 4-9 will treat at the selected dose level of Clofarabine and Cyclophosphamide.\n\nDose Level 2: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)","id":"EG001","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Decreased Leukocytes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":2}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Decreased ANC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":5,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":3,"numEvents":4}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Decreased Hemoglobin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Skin (due to shingles)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"AST, SGOT (serum glutamic oxaloacetic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Creatinine"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":5,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Failure to engraft"}]}